Randomized Study of the Use of Intravenous Choline Supplementation in Long Term Total Parenteral Nutrition
choline chloride
Enfermedades del Sistema Digestivo+3
+ Enfermedades del Hígado
+ Procesos Patológicos
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de noviembre de 1997
Fecha en la que se inscribió al primer participante.PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients receive either daily choline chloride in their total parenteral nutrition (TPN) solution or their usual TPN. The TPN is given intravenously over a 12 hour period beginning at approximately 9 PM nightly. Therapy continues for 24 weeks. Adjustments in the daily dose of choline provided may be required based on plasma free choline levels and patient tolerance. Additionally, all patients record the type and amount of their food intake on a daily basis. Patients are followed every 2 weeks during the first 6 weeks, then every 4 weeks beginning with week 12 for the remainder of the 24 weeks, and then again at week 34. Completion date provided represents the completion date of the grant per OOPD records
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 15 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 16 a 74 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Receiving nightly total parenteral nutrition (TPN) for greater than 70% of nutritional needs for a minimum of 8 weeks prior to study entry; Receiving no greater than 38 kcal/kg/day/ideal body weight; Receiving lipid emulsion as part of TPN regimen Expected to require TPN for at least 34 weeks after study entry Hepatic steatosis documented by prestudy CT scan Consistent daily amount of intravenous amino acids, dextrose, or lipid received for 3 weeks prior to study entry --Prior/Concurrent Therapy-- No concurrent cholinergic medications --Patient Characteristics-- Hepatic: Albumin at least 3.5 g/dL; No hepatic failure; PT no greater than 2 times upper limit of normal Renal: No renal failure requiring hemo- or peritoneal dialysis Other: No AIDS; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception